Cleared Traditional

DISPOSABLE SKIN MARKER (K915066) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K915066 · American Medical Mfg., Inc. · General & Plastic Surgery device
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May 1992
Decision
188d
Days
Class 1
Risk

K915066 is an FDA 510(k) clearance for the DISPOSABLE SKIN MARKER. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on May 14, 1992 after a review of 188 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4660 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Mfg., Inc. devices

Submission Details

510(k) Number K915066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date May 14, 1992
Days to Decision 188 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZZ Marker, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.